The present invention relates generally to a specimen testing apparatus and, more specifically, to a self-contained, tamper-proof system for screening for particular compounds (e.g., drugs and drug metabolites) and/or hormones (as in pregnancy test kits).
More businesses are requiring new employees to undergo pre-employment drug testing before hiring. Also, post-accident drug testing is almost routine, especially when flammable or hazardous waste hauling is involved, or where the safety of a large number of people are concerned (e.g., oil tanker captain, truck driver or high-speed train engineer). Normally, a urine specimen is taken and tested by a local lab. If the test turns up positive, the specimen must then be sent to a more sophisticated, usually remotely located, testing lab.
In order to ensure that there has been no tampering with the specimen and to prevent contamination of the specimen, several companies have developed self-contained screening devices. These self-contained screening devices usually comprise a specimen container having a screw-top lid and a plurality of reagent test strips suspended around the inner perimeter of the specimen container. The test strips turn a specific color in the presence of particular drug residues.
Home Pregnancy test kits operate in a similar manner. Each pregnancy test kits comprise a test strip designed to turn a specific color or to form a symbol (e.g. a xe2x80x9c+xe2x80x9d sign) in the presence of a hormone. The hormone appears in a woman""s urine only when she is pregnant.
Drug Free Enterprises, Inc., of Scott Valley, Calif., produces a self-contained urinalysis screening device that it markets under the name DRUGCHECK and claims to be able to detect a number of drug metabolites in minutes. Phamatech, Inc. of San Diego, Calif., markets a self-contained pregnancy test kit under the name CLEARCHOICE.
The present invention is a self-contained, tamper-proof screening/testing apparatus. The present invention consists of a container, a closure that snaps or screws onto the container and a cassette holding a rapid test strip that matingly engages with the closure.
A liquid specimen is stored in the container. A series of windows or inlets permit the operator of the testing apparatus to activate the test by inserting the cassette and/or turning the cassette thereby controlling the flow of the liquid specimen to the test strip. This invention is designed for testing a sample specimen in the container without opening the container. Further, the cassette is engaged on to the closure, the test may be conducted without having to physically access the specimen. The container of the present invention can then be mailed to an independent testing lab to confirm the test results without opening the closure, and without pouring the specimen into a new, shippable container. This feature has two important advantages; first, the nurse or other personnel supervising the test is not exposed to the specimen; second, it limits a person""s ability to tamper with the specimen, especially if the closure is equipped with a tamper-proof tape.
Besides providing means to physically activate the test when desired, the cassette is designed to allow the sample specimen to be shut off or isolated from the test area after the results are read, thereby preserving the remainder of the specimen.
After a patient has provided a specimen, the container can be sealed with the specially designed closure to prevent tampering and to prevent the accidental spilling of the specimen.
In another preferred embodiment, the closure has a substantially tubular portion that extends into the center of the container. This tubular portion is sized to accept a pipe section of the cassette. The tubular portion may be initially closed-off by a cap thereby forming a second, inner container within the first or original specimen container.